Alembic Pharmaceuticals Ltd announces USFDA Final Approval for Paroxetine Extended-Release Tablets USP, 12.5 mg

Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its supplemental Abbreviated New Drug Application (sANDA) Paroxetine Extended-Release Tablets USP, 12.5 mg. The approved sANDA is therapeutically equivalent to the reference listed drug product (RLD), Paxil CR Tablets, 12.5 mg, of Apotex Inc. Paroxetine extended-release tablets are indicated for the treatment of Major depressive disorder (MDD), Panic disorder (PD), Social anxiety disorder (SAD), and Premenstrual dysphoric disorder (PMDD). Refer label for a detailed indication.

Alembic has a cumulative total of 235 ANDA approvals (216 final approvals and 19 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 673.60 as compared to the previous close of Rs. 694.30. The total number of shares traded during the day was 12783 in over 1639 trades.

The stock hit an intraday high of Rs. 691.20 and intraday low of 666.00. The net turnover during the day was Rs. 8617555.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 FinalApproval USFDA sANDA Paroxetine ExtendedReleaseTablets